CK Group are recruiting for an Associate Regulatory Affairs to join a biopharmaceutical company at their site based in Uxbridge on a contract basis for 12 months.Company:
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.Location:
This Associate Regulatory Affairs role will be based at our clients site in Uxbridge, Greater London. Salary:
Up to £13.23 per hour PAYE.Associate Regulatory Affairs Role:
- The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents mostly related to clinical trials in the EU.
- Ensure compliance via timely submissions to regulatory agencies.
- Coordinate collection of functional documents in support of regulatory applications. Coordinate QC of regulatory documentation (e.g. briefing packages).
- Prepare regulatory packages and cross-reference letters to support investigator initiated studies.
- Complete regulatory forms to support agency communications (e.g. EudraCT).
- Good communication skills - oral and written.
- Organizational skills.
- Understanding of drug development process.
- Previous experience in pharmaceutical industry of at least 1 year is preferred in a regulatory affairs department.
For more information or to apply for this Associate Regulatory Affairs position, please contact CK Group, quoting job ref 48735.
It is essential that applicants hold entitlement to work in the UK.